Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Human Required)

The Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Humans Required), under funding opportunity number PAR-24-076, is offered by the National Institutes of Health (NIH), specifically through its Office of the Director and various institutes such as the National Cancer Institute, National Eye Institute, and National Institute on Aging. This grant supports early stage investigators (ESIs) proposing a new research direction devoid of preliminary data. It honors Dr. Stephen I. Katz and aims to promote novel, high-risk research initiatives by ESIs, encouraging innovation and bold shifts in scientific exploration. This grant is designed exclusively for basic experimental studies involving human participants that also meet the NIH's clinical trial definition. Research must represent a substantial departure from the applicant’s previous work and cannot be an incremental extension of prior studies. Instead, projects should present new methodologies, disciplines, therapeutic targets, or paradigms. A key feature is the strict prohibition on including unpublished preliminary data; any such inclusion will render applications noncompliant and ineligible for review. The grant accepts new and resubmission applications and is intended to cover actual project needs without a preset budget cap, though the maximum project period is five years. The NIH encourages proposals that are conceptually sound, highly innovative, and capable of significantly advancing scientific knowledge. Applications are reviewed based on factors such as significance, investigator qualifications, innovation, approach, and research environment. All project activities must be justified using previously published data, avoiding any citations that lack a DOI or that link to external URLs. Eligibility extends broadly to various entities, including state and local governments, nonprofits, for-profit entities, and academic institutions, with the stipulation that all PD/PIs must be NIH-designated ESIs. Foreign entities are not eligible to apply, though foreign components within U.S. organizations are permitted. All applicants must be registered with relevant federal systems including SAM.gov, eRA Commons, and Grants.gov, and applications must be submitted electronically via one of the specified platforms. Applications must include a dedicated attachment outlining how the proposed research diverges from previous work. Deadlines for submission occur multiple times annually, with the next due date for standard applications being May 28, 2025. The program is recurring with multiple review cycles through 2027, although the current expiration is set for May 24, 2025. Key contacts for scientific and financial questions are listed in the NOFO, including individuals from NIDCD, NIEHS, and NIMH. Awardees will be selected based on scientific merit, relevance to NIH priorities, and availability of funds. The grant promotes transparency and ethical research practices, including data management, human subject protections, and inclusivity. Upon award, recipients are bound by NIH policy terms, including post-award reporting requirements and compliance with data-sharing mandates.